An Open-label Pilot Study of Herceptin Monotherapy on Objective Treatment Response in Patients With Metastatic or Locally Advanced Gastric Cancer Who Had Disease Progression During Platinum-based or 5-fluoropyrimidine-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
研究概览
简要总结
This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients 18-75 years of age;
- •metastatic or advanced gastric cancer;
- •disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
- •>=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
- •>=1 measurable lesion;
- •HER2 overexpression (IHC [2+] or [3+]).
排除标准
- •concurrent chemotherapy or immunotherapy;
- •brain or meningeal metastases;
- •clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- •co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
- •women who are pregnant or breastfeeding.
研究组 & 干预措施
Trastuzumab Monotherapy
Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
时间窗: Weekly throughout study
Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than \[\<\]10 millimeters \[mm\]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).
次要结局
- Overall Survival - Number of Participants Who Died(Weekly throughout the study)
- Overall Survival(Weekly throughout the study)
- Percentage of Participants With Clinical Benefit(Weekly throughout the study)
- Percentage of Participants With a Best Overall Response of CR or PR(Weekly throughout the study)
- Time to Progression - Number of Participants With an Event(Weekly throughout the study)
- Time to Progression(Weekly throughout the study)